On January 19, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported it entered into an agreement with Sirtex Medical, Inc. (Sirtex) granting Sirtex an option to non-exclusively co-promote the Company’s lead product candidate, TAVO (tavokinogene telseplasmid) in anti-PD-1 checkpoint refractory metastatic melanoma in the U.S (Press release, OncoSec Medical, JAN 19, 2021, View Source [SID1234574104]). By entering into this co-promotion, OncoSec intends to capitalize on both the extensive experience Sirtex has in marketing drug/device combination products, as well as their established oncology sales force in the U.S.
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Daniel O’Connor, President and Chief Executive Officer of OncoSec, stated, "Sirtex is a strong company with significant experience in the sales and marketing of drug/device combination products to treat cancer. This deal provides OnocSec with the potential to commercialize TAVO with a highly skilled U.S. sales force in this initial indication, while retaining the right to grant others the ability to do so and the flexibility to buy back the rights if warranted."
Under the terms of the agreement, Sirtex will pay OncoSec $5 million for a non-exclusive option to co-promote TAVO in combination with KEYTRUDA in patients with anti-PD-1 checkpoint refractory metastatic melanoma in the U.S. If exercised, this option would require Sirtex to pay an additional $20 million in cash and purchase $5 million in common stock of the Company at a market price. The option must be exercised by Sirtex within 90 days of OncoSec’s filing a Biologics License Application (BLA) with the FDA and carries a co-promote term of eight years. OncoSec reserves the right to grant others co-promotion rights, as well as the right to buy back the co-promotion rights for a certain amount determined by the remaining number of years left in the term, but not to exceed $45 million.
Kevin Smith, Chief Executive Officer of Sirtex, stated, "Sirtex has an established oncology sales force in the U.S. and welcomes the opportunity to leverage our resources to market TAVO in patients with anti-PD-1 checkpoint refractory metastatic melanoma in the U.S. We are very impressed with the progress OncoSec has made to date and believe that TAVO represents a viable opportunity to address this high unmet medical need."
If exercised, the option would require Sirtex to field a sales force to promote TAVO among key target audiences to be agreed upon by OncoSec and Sirtex. To support these efforts, OncoSec will provide materials to help train Sirtex’s team of sales representatives. The companies will share the sales and marketing costs, with OncoSec assuming approximately two thirds of such costs and Sirtex assuming approximately one third. OncoSec will pay Sirtex a high-teens royalty on net sales in the indication in the U.S. The companies will establish a joint committee pertaining to sales and marketing activities to be undertaken, with OncoSec retaining final decision making authority for all matters relating to TAVO, including, but not limited to, pricing, supply terms, manufacturing and clinical trials. Additionally, OncoSec shall invoice and book all sales.
Sirtex is a global healthcare business with offices in the U.S., Australia, Europe and Asia, working to improve outcomes in people with cancer. Sirtex’s current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,400 medical centers in over 50 countries. For more information, visit www.sirtex.com.
About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S.Food & Drug Administration for the treatment of metastatic melanoma.